AUGMENTIN™ in Dental Infections (AUGDENT)

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In clinical practice, amoxicillin + clavulanic acid is widely used in the treatment of odontogenic infection. Therefore, this study is designed to generate data to support its use by demonstrating efficacy, safety and tolerability in comparison with clindamycin in subjects with acute odontogenic infections with or without abscess. This will be a two-arm, parallel, comparative, observer blind, randomised study to assess efficacy, safety and tolerability of amoxicillin + clavulanic acid (875mg/125mg) in comparison with clindamycin (150mg) administered for 5-7 days in subjects with acute odontogenic infections with or without abscess. The study will be performed in adult subjects both male and female ≥18 years of age who present with acute odontogenic infections. A total of 472 subjects will be randomized in 1:1 ratio, i.e. 236 subjects in each treatment arm. The treatment duration of the study will be at least 5 days or maximum 7 days depending upon the treatment response. Subjects will be assessed on Day 5 and if Investigator feels the need of continuing the treatment at Day 5 then treatment will be continued till Day 7. For subjects who do not show treatment response on Day 5, assessments will be performed on Day 7.

Efficacy, Safety and Tolerability of Amoxicillin + Clavulanic Acid (875mg/125mg) Two Times a Day Compared to Clindamycin (150mg) Four Times a Day for 5-7 Days in Treatment of Acute Odontogenic Infection With or Without Abscess

Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7) [ Time Frame: Day 5 or Day 7 [End of treatment] ]

Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.

Secondary Outcome Measures :

Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5 [ Time Frame: Day 5 ]

Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.

Number of Participants (Par.) Achieving Clinical Success (CS) (Cure or Improvement [Imp] in Signs [s] and Symptoms [sx] [s/sx]) Without Considering Clinical (cl) Judgment (Jdg) of the Investigator (Inv) at Day 5 [ Time Frame: Day 5 ]

CS is defined as cure or imp in s/sx of odontogenic infections. Cure is defined as the complete resolution of s/sx of infection present at Baseline (BL) and imp is defined as resolution of fever (if present at BL), >70% reduction in swelling and pain and imp in other s/sx such that no additional antimicrobial (ant) therapy is required. In event of cure or imp with complete resolution of fever and >70% reduction in swelling and pain, but 'no change' or 'worsening from BL' in other s/sx (like increased leucocyte count/tooth mobility), the inv's opinion was sought on whether additional ant therapy was required. Par. that required no additional ant therapy were considered a 'success' while those requiring additional ant therapy were deemed a 'failure'. For a sensitivity analysis, all such par. with 'no change' or 'worsening from BL' in these other s/sx were considered as cl failures and termed 'Without Considering Cl Jdg of Inv', even though main s/sx are 'cured' or 'improved'. .

Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7 [ Time Frame: Baseline, Days 2, 5 and 7 ]

Visual Analogue Scale (VAS) is used to measure the amount of pain that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).

Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7 [ Time Frame: Baseline, Days 2, 5 and 7 ]

Visual Analogue Scale (VAS) is used to measure the amount of swelling that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no swelling and 10 indicates worst possible swelling. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).

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Layout table for eligibility information

Ages Eligible for Study:

18 Years to 75 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Inclusion Criterion:

Adult (≥18 years of age) males and females

Subjects with diagnosis of acute odontogenic infections of following types requiring antibiotic therapy

Subjects with a known clinically significant abnormality identified at screening on physical examination or known laboratory tests which, in the judgment of the Investigator, would preclude safe completion of the study

Subject who has taken a systemic antibiotic within 2 weeks before study drug administration or a long-acting injectable antibiotic (e.g., penicillin G benzathine) within 4 weeks before study drug administration

Immunocompromised subjects or subjects on immunosuppressants or systemic corticosteroids

Subjects with chronic gingivitis or chronic periodontitis

Subjects with uncontrolled diabetes mellitus or HIV infection

History of hypersensitivity or allergic reactions to any beta-lactam such as penicillin, cephalosporin, moxicillin/clavulanic acid or clindamycin

Concomitant infection, that requires additional antimicrobial therapy during the study period

Subjects with clinically significant liver disease as defined by alanine aminotransferase (ALT) or aspartate minotransferase (AST) levels >2.5 times the upper limit of normal (ULN) or a diagnosis of chronic active hepatitis including that of viral etiology, or on antiviral or immunosuppressive therapy.

Subjects with renal impairment with serum creatinine > 1.7 mg/dl in men and >1.5mg/dl in women.

Subjects with infectious mononucleosis

Subjects with history of documented Clostridium difficile-associated diarrhoea or existing diarrhoea